Browse Device Recalls
5,543 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,543 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 5,543 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: a) ENDO KIT, REF DYKE1410A | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: DENTAL, REF DYNJ909211A | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: a) KIT CANISTER SUCT W ... | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: a) TURNOVER KIT, REF DY... | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: a) AAA CDS, REF CDS9840... | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: a) BASIC NASAL, REF D... | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: a) CYSTO, REF DYNJ90500... | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: a) HEART ANESTHESIA SET... | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 20, 2024 | 3M Durapore Surgical Tape, Catalog Number 1538-118 | Select lots of the 3M Durapore Surgical Tape, Catalog Number 1538-118, were incorrectly labeled w... | Class II | 3M Company - Health Care Business |
| Mar 15, 2024 | Palindrome Precision H Chronic Catheter Kit 14.5 Fr/Ch (4.8mm) x 23 cm (Sym... | Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit... | Class II | Covidien LP |
| Mar 15, 2024 | Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 9119... | Elekta has become aware that Disposable Biopsy Needles (911933) from one batch (837838839) can co... | Class I | Elekta Instrument AB |
| Mar 15, 2024 | Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 1... | Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit... | Class II | Covidien LP |
| Mar 14, 2024 | Prelude Guide Sheath Roadster, REF PG6F45S018, 6F 0.087" (2.2 mm), 45 cm, STE... | Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator. | Class II | Merit Medical Systems, Inc. |
| Mar 14, 2024 | Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STER... | Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator. | Class II | Merit Medical Systems, Inc. |
| Mar 13, 2024 | Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Numb... | Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing pro... | Class II | Biomet, Inc. |
| Mar 12, 2024 | ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Co... | Product incorrectly labelled. | Class II | DePuy Orthopaedics, Inc. |
| Mar 5, 2024 | Bed Assist Bars, labeled as follows: a) Medline SwivAssist Bar, Model Numb... | Medline is recalling certain lots of our Adult Portable Bed Rails that were manufactured after th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 5, 2024 | Bed Assist Bars, labeled as follows: a) Medline, Model Number BA6800, b)... | Medline is recalling certain lots of our Adult Portable Bed Rails that were manufactured after th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 4, 2024 | NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descrip... | The expiration date was not printed on the outer shipping label, leading to expired syringes bein... | Class III | Avanos Medical, Inc. |
| Mar 4, 2024 | NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descrip... | The expiration date was not printed on the outer shipping label, leading to expired syringes bein... | Class III | Avanos Medical, Inc. |
| Mar 4, 2024 | NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descrip... | The expiration date was not printed on the outer shipping label, leading to expired syringes bein... | Class III | Avanos Medical, Inc. |
| Mar 1, 2024 | VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Ca... | Potential for positively biased results due to signal reduction over shelf life. | Class II | Ortho-Clinical Diagnostics, Inc. |
| Mar 1, 2024 | Medline medical procedure kits, labeled as follows: a) PARACERVICAL PUD TR... | Trumpet Needle Guide ring can detach when excessive pressure is applied. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion scalpel handle kits labeled as: a) STERILE # 3 SCALPEL HANDLE, Pro... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion Curette kits labeled as: a) STERILE BUCK EAR CURETTE "00" (25697)... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion Manual surgical kits labeled as: a) 15ML SAMPLING TUBE WITH CAP,... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion manual surgical kits labeled as: a) ST. VIRTUS SPLINTER FORCEP 6"... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product ... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion Manual surgical kits labeled as: a) HEGAR UTERINE DILATOR, 11-12... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion manual surgical kits labeled as: a) STERILE TUBE OCCLUDING FORCEP... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion Manual surgical kits labeled as: a) STERILE S/B WIRE SCISSOR, Pr... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion Forcep kits labeled as: a) STERILE F/P SPLINTER FORCEP (SF6141), P... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | The LeadCare¿ II Blood Lead Test System relies on electrochemistry and a uniq... | Calibration Buttons being used in the kitting process were incorrectly labeled as Lot 2323M for l... | Class II | Magellan Diagnostics, Inc. |
| Feb 23, 2024 | Centurion hook kits labeled as: a) STERILE SKIN HOOK FINE (EA3975F), Product... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion manual surgical kits labeled as: a) STERILE ALLIS TISS FCP 10", P... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion Clamp kits labeled as: a) STERILE BACKHAUS TOWEL CLAMP (BTC173), ... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion retractor kits labeled as: a) STERILE 6-1/2" SENN RETRACTOR (ST718... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion Hemostat kits labeled as: a) STERILE CURV KELLY HEMOSTAT, Product... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion manual surgical kits labeled as: a) STERILE 4-1/2" S/S SCISSOR (S... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 21, 2024 | HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H. | It was discovered through a customer complaint that mislabeled product was distributed. Puritan d... | Class II | Puritan Medical Products Company, Llc |
| Feb 21, 2024 | ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20. | The reason for the recall is the failure of calibration and quality controls due to a manufacturi... | Class II | Abbott Laboratories |
| Feb 20, 2024 | HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100) | Product was mislabeled as a Surgical Cap at its dispenser level. | Class III | O&M HALYARD, INC. |
| Feb 7, 2024 | Access Substrate, REF 81906, For use with the Access Immunoassay Systems | On 07 February 2024 Beckman Coulter made the decision to conduct a field action on Access Substra... | Class II | Beckman Coulter, Inc. |
| Feb 7, 2024 | Medtronic DLP Vessel Cannula, Model Number REF 30000 | Medtronic is writing to inform you of incorrect labeling for three manufactured lots of the DLP V... | Class II | Medtronic Perfusion Systems |
| Feb 6, 2024 | SPII Model Lubinus, Hip Prosthesis Stem XL Neck, cemented | Due to two complaints, has come to our attention that additional guidance is required on the corr... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Feb 6, 2024 | SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented | Due to two complaints, has come to our attention that additional guidance is required on the corr... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Feb 6, 2024 | SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented | Due to two complaints, has come to our attention that additional guidance is required on the corr... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Feb 6, 2024 | SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented | Due to two complaints, has come to our attention that additional guidance is required on the corr... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Feb 2, 2024 | BVI Visitec Irrigation Handle (20/SP)- Intended to be fit with a cannula for ... | Pack and pouch label is missing the manufacturing and expiration date. | Class II | Beaver Visitec International, Inc. |
| Jan 26, 2024 | I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175 | This Field Action is being conducted following the identification of a batch mix-up between I.B.S... | Class II | In2Bones, SAS |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.